Quick Facts at a Glance
- Recall Date
- December 26, 2025
- Hazard Level
- HIGH
- Brand
- Gold Star Distribution
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Drug Safety; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Gold Star Distribution
- Product type
- OTC Digestive Health Medication
- Model numbers
- All lots within expiry distributed by Gold Star Distribution.
- Sizes
- 32-count
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
December 26, 2025
Reported by FDA DRUG
January 21, 2026
RecallRadar source check
March 18, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
What You Should Do
Consumers and healthcare providers should stop using this product immediately. Contact GOLD STAR DISTRIBUTION INC or your healthcare provider for guidance. Notification method: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
About This Product
Pepto Bismol is an over-the-counter digestive health medication used to relieve upset stomach, indigestion, and diarrhea. This recall concerns packaging distributed nationwide by Gold Star Distribution.
Why This Is Dangerous
CGMP deviations led to insanitary conditions, including rodent exposure at the distribution center. This raises the risk of product contamination.
Industry Context
This recall is not described as part of a broader industry pattern.
Real-World Impact
Consumers could experience illness if contaminated. Immediate cessation of use is advised pending guidance and potential refunds.
Practical Guidance
How to identify if yours is affected
- Check if your bottle is Pepto Bismol 32-count distributed by Gold Star Distribution.
- Verify expiry date and compare to the lots described in the recall notice.
- Inspect for packaging that references Gold Star Distribution as the distributor.
Where to find product info
FDA recall page linked in the notice and the product packaging.
What timeline to expect
Refunds or replacements typically take 4-6 weeks after the claim is submitted.
If the manufacturer is unresponsive
- File a complaint with FDA or your state consumer protection office.
- Keep records of your recall notices and any correspondence with the distributor.
How to prevent similar issues
- Buy from reputable retailers and verify distributor information.
- Watch for recall notices on the FDA recall database.
- When purchasing medicines, check packaging and lot numbers for authenticity and safety certifications.
Documentation advice
Keep the product packaging, receipts, and recall notices. Save correspondence with the distributor for your records.
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Product Details
Product: Pepto Bismol 32-count tablets (OTC digestive health medication)\nBrand: Pepto Bismol\nDistributor: Gold Star Distribution Inc\nRecall date: 2025-12-26\nStatus: Active\nHazard: CGMP deviations; unsanitary conditions; rodent exposure at distribution center\nSold nationwide in the United States\nExpiry: All lots within expiry distributed by Gold Star Distribution\nPrice: Unknown\nModel numbers: All lots within expiry distributed by Gold Star Distribution.
Key Facts
- Active recall for Pepto Bismol 32-count distributed by Gold Star Distribution
- CGMP deviations and insanitary conditions cited at the distribution center
- Rodent exposure/activity identified as a contributing factor
- All lots within expiry distributed by Gold Star Distribution are affected
- Nationwide distribution in the United States
- No injuries reported in the notice
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Safety Guide
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